FDA.reportPublic FDA data

Bovie

Primary DI
10607151069053
Brand
Bovie
Company
BOVIE MEDICAL CORPORATION
Model
ST05
Catalog number
ST05
Device description
SURCH-LITE ™ SURGICAL LIGHT 5'' (12.7cm)
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTFIlluminator, Non-Remote

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTFIlluminator, Non-RemoteGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151069053PackageGS110In Commercial Distribution
00607151069056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715106905310607151069053
00607151069056006071510690566071510690560607151069056

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held examination/treatment lightA small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079940465
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607151009854BovieE15646E156462020-11-16
00607151009861BovieE15644E156442020-11-16
00607151009878BovieE15596E155962020-11-16
00607151009885BovieE15606E156062020-11-16
00607151009892BovieE15616E156162020-11-16
00607151009908BovieE15626E156262020-11-16
00607151009915BovieE15594E155942020-11-16
00607151009922BovieE15604E156042020-11-16
00607151009939BovieE15614E156142020-11-16
00607151009946BovieE15624E156242020-11-16
00607151009953BovieE16512E165122020-11-16
00607151009960BovieE16514E165142020-11-16
10607151010796BOVIEBA3350ABA3350A2016-10-07
10607151010819BOVIEBA3390ABA3390A2016-10-07
10607151010826BOVIEBA3390NABA3390NA2016-10-07
10607151010833BOVIEBA3350NABA3350NA2016-10-07
10607151010840BOVIEBA2455NABA2455NA2016-10-07
10607151010857BOVIEBA1860NABA1860NA2016-10-07
10607151007604J-PLASMA® GS-270CGS-270C2016-09-21
10607151007819J-PLASMA® GS-018CGS-018C2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607915142087Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONFTF2026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONFTF2026-04-22
10607151002258BovieASPEN SURGICAL PRODUCTS, INC.FTF2017-02-10
00885380024798CARDINAL HEALTHCardinal Health 200, LLCFTF2016-12-29
20885380024792CARDINAL HEALTHCardinal Health 200, LLCFTF2016-12-29
00607151069056BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
00607151069100BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
00607151069155BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
10607151069107BovieBOVIE MEDICAL CORPORATIONFTF2016-10-17
10607151069152BovieBOVIE MEDICAL CORPORATIONFTF2016-10-17